Regional Contracts Lead – Clinical Site Contracts

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🔥 1 minute ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

👻 Ghost score 10%

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Logo of BeOne Medicines

BeOne Medicines

10,000+ employees

Founded 2010

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

Biotechnology • Healthcare • Pharmaceuticals

BeOne Medicines is a global oncology company domiciled in Switzerland that is discovering and developing innovative treatments that are more affordable and accessible to cancer patients worldwide. With a portfolio spanning hematology and solid tumors, BeOne is expediting the development of its diverse pipeline of novel therapeutics through its internal capabilities and collaborations. With a growing global team of more than 11,000 colleagues spanning six continents, the Company is committed to radically improving access to medicines for far more patients who need them.

📋 Description

• Oversee and ensure on-time execution of regional clinical contract agreements, including CTAs, investigator agreements, confidentiality agreements, ancillary agreements, pharmacy agreements, site master service agreements, consulting agreements, single-service agreements, and subcontractor agreements • Manage the regional Clinical Contracts team, including Contract Managers and Contract Associates or equivalent • Deliver individual and group feedback to support ongoing team development • Sign Investigator Contracts under POA when authorized by BeOne Medicines Legal and Tax • Maintain and improve negotiation processes to meet financial and operational needs • Ensure clinical site budget negotiations remain within fair market value and internal approval guidelines • Partner with Clinical Operations and CBO colleagues to improve clinical site contract and budget metrics and implement processes • Apply standards across clinical site contract and budget processes and support continuous improvement while developing TA-aligned strategies • Serve as regional escalation point for Clinical Site Contracts and provide regional program-level oversight • Use industry tools and data sources to provide budget and contract feedback aligned with company parameters and fair market value guidance • Identify potential delays, provide solutions, and escalate nonperformance • Provide oversight and guidance for clinical site contract negotiations, identify risks, and manage contracting timelines and lifecycle • Ensure regional contracts are completed according to company standards and timelines; implement mitigation plans as needed • Develop and implement policies and procedures based on identified needs • Perform other tasks requested by departmental and company leadership

🎯 Requirements

• Bachelor’s degree; JD highly preferred or 8+ years of outstanding experience managing and negotiating clinical trial agreements and budgets • Experience in the CRO or pharmaceutical industry is essential • Good knowledge of ICH-GCP, pharmaceutical-related regulations and laws • Good understanding of clinical trial contracting processes and relevant clinical operations practices • Awareness and understanding of compliance and regulatory matters in clinical research • Proven negotiation, interpersonal, and business skills • Strong planning and organizational skills; ability to work independently and effectively in a dynamic environment with competing priorities • Sense of urgency and strong goal orientation; track record of meeting deadlines and goals • Strong written and verbal communication, including fluency in English and local language if not English • Strong interpersonal skills, including conflict resolution and problem solving • Proactive and positive team player; able to maintain high performance during ambiguity and change • Financial, budget, cost management/analysis, accounting, and/or financial planning skills are desirable • Knowledge of intellectual property, publication, indemnification, and other standard clinical site contract issues • Willingness to work in a fast-paced environment with time-sensitive material • Demonstrated ability to work effectively at all levels of an organization • Microsoft Office apps, CTMS, Contract Lifecycle Management System, Veeva, Jira, SharePoint, etc. • Willingness to travel 10%

🏖️ Benefits

• Market competitive compensation package including performance-based annual bonus scheme • Company shares (generous welcome grant!) • In-house and external learning and development opportunities • Fantastic benefits program • Opportunity to work with a dynamic, collaborative, supportive, inclusive, and fun team

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